Euro Convergence: Experts emphasize careful planning for market launch strategy

BRUSSELS – While the US has more recently been viewed as the market of choice for medtech product launches, recent political and economic developments have led companies to reconsider which markets to target first. Experts advised manufacturers to consider factors such as investor needs, access to patients in clinical studies, and available regulatory pathways when deciding which markets to bring their products to, and in what order.

A panel of experts discussed regulatory strategies for medical device and in vitro diagnostics makers to decide which market to bring their products to first at RAPS Euro Convergence 2025.

Panel moderator Kristiane Schmidt, principal consultant at Qserve, said that companies should first understand the intended purpose of the product they plan to market when piecing together their regulatory strategy. She also said they need to make decisions early on that they are willing to stick to, yet be flexible enough to change their strategy if necessary.

Schmidt said companies need to understand the regulatory environment they intend to enter, which means identifying similar and competitor devices in the market. They also need to identify standards, product-specific requirements, guidances, and classifications that apply to their product in those jurisdictions. Before deciding what market to enter, she also said it’s crucial to compare different market requirements, including regulatory pathways, anticipated timelines to market, and the associated costs.

Other vital factors to consider, Schmidt said, are the location of the product maker's company, access to key opinion leaders and payers, the size of the market, unmet need for the product, and whether the company size and access to resources means taking a stepwise or a parallel product development approach. Access to patient samples and clinical study sites, reimbursement pathways, data generation, competition, and regulatory barriers are also key factors to consider.

Sue Spencer, director of Compliance Connextions, said companies should also consider the market value of their product, where the key opinion leaders and investors are based, and whether investors prefer one market over another.

Spencer compared the EU and the US markets, and noted that while Europe isn’t the largest market, CE marking is recognized in 120 countries, which can be an incentive. She added that companies considering the EU market must reckon with some instability due to evolving regulations, like the In Vitro Diagnostics Regulation (IVDR), which could make the region less attractive for some companies.

“I remember when I came into the industry people used to fear [the US Food and Drug Administration] FDA, but now they almost prefer FDA because it’s established,” said Spencer. “You kind of know what’s going on. Timelines were predictable. Obviously, we’ll see what happens in the future.”

Spencer said that there are no early engagement programs to support innovation in the EU, and clinical performance studies (CPS) must be discussed individually with each national competent authority (NCA) where they are conducted. She added that product development costs are less predictable in the EU as they depend on the time to review, which can depend on several factors. She also noted that the average review time is 18 months, but that is starting to come down depending on the quality of the product application and the type of product.

While FDA offers several benefits for companies that want to enter the US market first, such as a well-established regulatory framework, early engagement through its pre-submission program, more predictable costs and timelines, and breakthrough device programs, Spencer noted that President Donald Trump's tariffs have created more uncertainty.

“[The US] has been the destination of choice in the last few years but whether that will remain we’ll have to see,” she added.

Spencer said that sometimes it’s not a matter of choosing what market to go to first but rather choreographing the company’s product development so they can manage multiple regulatory regimes based on market access programs such as FDA's Breakthrough Device Program and the UK's Innovative Devices Access Pathway (IDAP) program. Part of that calculation could also include teeing up the product for different conformity routes, such as the UK's recent decision to allow FDA-authorized class B devices on the market after being self-declared.

“Just be aware that the devil is in the details, and some of the conformity routes aren’t the same,” she added. “There can be winners and losers from this… but there are opportunities as well.”

Spencer also listed specific factors that start-ups and novel device companies should consider. She noted that start-ups should factor in their investors' expectations, whether they will need funds to scale up before commercialization, and their development milestones. For companies planning to market novel devices, she noted they should take opportunities to talk about their device with regulators early in the development stage, be aware that they can't afford to redo studies, and ensure they have good data.

Euro Convergence: Experts emphasize careful planning for market launch strategy

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